Pharmacovigilance

Our pharmacovigilance support ranges from full, 24/7 assistance service with global coverage, to tailored services based on client needs.

Materiovigilance

Biomapas not only supports Marketing Authorisation Holders with safety surveillance of medicinal products, but also supports manufacturers and/or distributors of medical devices with safety surveillance. Our services include:

  • Pre- and post-marketing safety surveillance services for all classes of medical devices
  • Processing and handling of Incidents and Near Incidents
  • Reporting of Incidents and Near Incidents to relevant authorities
  • Preparation and submission of Periodic Summary and Trend reports
  • Handling of quality complaints

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

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